Efficacy

PENETRATION & ERECTION MAINTENANCE

LITTLE BLUE PILLTM. Significant efficacy.

In a retrospective analysis of data pooled from 5 flexible-dose studies of men with ED, those taking VIAGRA saw significant improvement in penetration and erection maintenance vs placebo

Ability to penetrate (IIEF Q3)

IIEF=International Index of Erectile Function.
Ability to maintain an erection (IIEF Q4)
IIEF=International Index of Erectile Function.
  • Study Description

    Results from a retrospective analysis of data pooled from one phase 2 and four phase 3 double-blind, flexible-dose, placebo-controlled studies with 1370 patients with ED who took at least one dose of VIAGRA and/or placebo study medication. The primary efficacy end points included Questions 3 and 4 of the 15-question International Index of Erectile Function (IIEF) questionnaire. The IIEF contains 5 domains of sexual function which consist of specific IIEF questions: erectile function (EF) domain, (Q1-5, and Q15), score: 0-30; intercourse satisfaction (IS) domain, (Q6-8), score: 0-15; orgasmic function (OF) domain, (Q9-10), score 0-10; sexual desire (SD) domain, (Q11-12), score: 0-10; and overall satisfaction (OS) domain, (Q13-14), score: 0-10. For EF, the Group Baseline Mean for men with ED taking VIAGRA (n=625) was 10.82 vs 10.75 for placebo (n=600). At End of Treatment (EOT), the Mean Group score was 20.98 for VIAGRA vs 11.45 for placebo. The post-hoc analysis for the EF domain suggested a 94% change from Baseline for VIAGRA vs 7% for placebo (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo). For IS, the Group Baseline Mean for VIAGRA (n=627) was 5.48 vs 5.39 for placebo (n=606). At EOT, the Group EOT Mean was 9.86 for VIAGRA vs 6.48 for placebo. The analysis for the IS domain suggested a 78% change from Baseline for VIAGRA vs 19% for placebo (P<.0001, based on Least Squares mean of percent change from Group Baseline Mean). In the OF domain, the Group Mean Baseline for VIAGRA (n=622) was 5.00 vs 4.95 for placebo (n=605). At EOT, the Group EOT Mean was 6.73 for VIAGRA vs 5.05 for placebo. The analysis for the OF domain suggested a 37% change from Baseline for VIAGRA vs 5% for placebo (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo). In the SD domain, the Group Baseline Mean for VIAGRA (n=627) was 6.89 vs 6.76 for placebo (n=610). At EOT, the Group EOT Mean for VIAGRA was 7.16 vs 6.59 for placebo. The analysis for the SD domain suggested a 3% change from Baseline for VIAGRA vs -2% for placebo (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo). In the OS domain, the Group Baseline Mean for VIAGRA (n=630) was 4.74 vs 4.60 for placebo (n=604). At EOT, the Group EOT Mean for VIAGRA was 7.31 vs 5.00 for placebo. The analysis of the OS domain suggested a 54% change from Baseline for VIAGRA vs a 10% change for placebo (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo).

    In this post-hoc analysis for all domains, percent change from Baseline was calculated: ([Subject-Level End of Treatment Value minus Group Baseline Mean]/Group Baseline Mean x 100)

HARDNESS

LITTLE BLUE PILL. Hardness matters.

In this double-blind, placebo-controlled study of men with ED, erection hardness, as measured by the EHS, was a secondary endpoint.2

Patients reporting erections hard enough for intercourse2†(Erection Hardness Score [EHS] 3 or 4), VIAGRA vs placebo

  • Learn More About the EHS
     
  • Study Description

    Results from the last 4 weeks of a double-blind, placebo-controlled, parallel-group, fixed-dose, as-needed study of patients with ED taking VIAGRA 25 mg, 50 mg, or 100 mg (N=532). Primary end points were change in erectile function as measured by Q3 and Q4 of the IIEF. Q3: "When you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?" (Baseline: VIAGRA 100 mg=2.0, placebo=2.1; end point: VIAGRA 100 mg=4.0, placebo=2.2; P<.001 for all doses of VIAGRA vs placebo). Q4: "During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?" (Baseline: VIAGRA 100 mg=1.7, placebo=1.7; end point: VIAGRA 100 mg=3.9, placebo=2.1; P<.001 for all doses of VIAGRA vs placebo). Erection hardness was measured by patient-reported scoring on the EHS in the event log. Of patients taking VIAGRA 25 mg (n=97), 50 mg (n=105), and 100 mg (n=102), 72%, 80%, and 85% reported erections hard enough for sexual intercourse (EHS grade 3 or 4), respectively, compared with 50% of patients taking placebo (n=205; P<.001). EHS grade 1 indicates that the penis is larger but not hard; grade 2, that the penis is hard but not hard enough for penetration; grade 3, that the penis is hard enough for penetration but not completely hard; and grade 4, that the penis is completely hard and fully rigid.

    Patients in studies had varying degrees of ED. Patients reported successful intercourse at least once during a 4-week, treatment-free run-in period. In general, VIAGRA patients who were less impaired at baseline responded best.

COMORBID CONDITIONS

LITTLE BLUE PILL. For a broad range of patients with ED.

VIAGRA has been studied in over 23,000 men with ED and common comorbidities1

Patients with ED and diverse comorbidities in VIAGRA clinical trials1

Other comorbidities studied, but not included above: hyperlipidemia, ischemic heart disease, benign prostate hyperplasia, and multiple sclerosis.

 

OTHER PATIENT TYPES

LITTLE BLUE PILL. Results for difficult-to-treat patients.

Patients were asked "Has treatment improved your erections?" (GEQ)

Men with ED after spinal cord injury (SCI)

Men with ED after SCI were nearly 7 times more likely to report improvement with VIAGRA compared with placebo.
  • Study Description

    Results from a randomized, double-blind, placebo-controlled, crossover, flexible-dose study of 178 men with ED resulting from spinal cord injury. Men were asked a global improvement question to assess whether treatment improved their erections.

Men with ED after radical prostatectomy (RP)

Men with ED after RP were nearly 3 times more likely to report improvement with VIAGRA compared with placebo.

  • Study Description

    Results were from 142 patients included in the 21 randomized, double-blind, placebo-controlled trials of more than 3000 men aged 19 to 87 years, with ED of various etiologies with a mean duration of 5 years. Studies had a duration of up to 6 months, and used a variety of study designs (fixed dose, titration, parallel, crossover). In most studies, the effectiveness of VIAGRA was evaluated using several assessment instruments. The primary measures in the principal studies were Q3 and Q4 of the IIEF. VIAGRA demonstrated statistically significant improvement compared with placebo in these studies.

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References
1. Data on file. Pfizer Inc, New York, NY. 2. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA; for the Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med. 1998;338(20):1397-1404. 3. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the Erection Hardness Score. J Sex Med. 2007;4(6):1626-1634.